29 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
Carbide burs
FDA UDI
DFS - DIAMON GmbH·04057176153357·Carbide 21 FG 1,6 mm
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009601·BELLA STRONG 20-30 MM HG ARMSLEEVE DOT BAND SIZ...
PERMACEM / PERMACEM DUAL
FDA 510(k)
FDA Class 2
·Dental
PHOENIX DIGITAL EEG
FDA 510(k)
FDA Class 2
·Neurology
MICRUSFRAME10 6MM X 11.9CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·July 8, 2022
PLV-100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 30, 2013
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 15, 2021
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FPA·October 6, 2021
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 6, 2021
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 22, 2021
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 18, 2021
EVOKE SCS SYSTEM
FDA Adverse Event
Injury
·SALUDA MEDICAL PTY LTD·Product code LGW·February 13, 2024
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025